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100mL ENFit GPro Syringe Purple Sterile 120008323

by Avanos Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00350770008998 UDI-DI Date19 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
100mL ENFit GPro Syringe Purple Sterile
Generic Name
ENFit oral/enteral syringe, single-use
Model / Ref / Catalog
120008323, PNM-S100NCV
Primary DI / UDI-DI
00350770008998
510(k) Number
FDA Product Code
PNR
GMDN Term
ENFit oral/enteral syringe, single-use
Device Class
Class II
Regulation Number
876.5980
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K161039)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No